FDA publishes a final guidance on using comparability protocols for postapproval changes in chemistry, manufacturing, and controls information in NDAs...
FDA solicits input on a discussion paper raising regulatory issues and questions about direct manufacturing and point-of-care manufacturing of drugs.
The CDER Office of Prescription Drug Promotion says it wants to research how consumers and healthcare providers interpret prescription drug names.
FDA says Palm Harbor, FL-based Regener-Eyes is illegally marketing its Regener-Eyes Ophthalmic Solution.
Federal Register notice: FDA extends the comment period for a draft guidance entitled Laser-Assisted In Situ Keratomileusis (LASIK) Lasers Patient La...
Federal Register notice: FDA announces a voluntary Total Product Life Cycle Advisory Program pilot that was agreed to between FDA and industry as part...
FDA expands the emergency use authorization for the Moderna and Pfizer/BioNTech bivalent Covid vaccine booster shots to cover children age six and old...
Evofem Biosciences discontinues its EVO100 development program of a drug to prevent chlamydia and gonorrhea in women.
